International standards: their new role in a global economy

Abstract

International standards for quality and dependability have increased importance in national and international trade because of efforts to harmonize standards in many parts of the world. Today's quality and reliability professional must have a concrete understanding of the international standards, their sources, and their content. This presentation explains the framework for the quality system standards based on the ISO 9000 series and the IEC standards relating to reliability and safety techniques. The paper applies these standards to the medical device industry, in both the United States (US) and the European Union (EU), to illustrate their use. Changes in the medical device industry regulations in both the US and EU demonstrate the role of these standards and their importance in global harmonization. In the US, the international standards will directly supplant many standards known today. Standards bodies may also adopt international standards and reissue them in their own numbering system. In either case, quality and reliability professionals must have a working knowledge of the structure, content, and direction of international standards.